N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991-1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This study was carried out in accordance with the OECD Guideline No. 406, *Skin Sensitisation*, the EEC Directive 84/449/EEC, Part 8.6, *Skin Sensitisation* and in accordance with the method described by Magnusson and Kligman, 'Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens. A GLP certificate is provided.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The testing using the guinea pig maximisation test protocol was completed on 17 April 2009. The LLNA 429 was not formally adopted by the OECD until 22 July 2010.

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine

EC Number:

223-362-3

EC Name:

N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine

Cas Number:

3855-32-1

Molecular formula:

C11H27N3

IUPAC Name:

(3-{[3-(dimethylamino)propyl](methyl)amino}propyl)dimethylamine

Test material form:

gas under pressure: refrigerated liquefied gas

In vivo test system

Test animals

Species:

guinea pig

Strain:

Himalayan

Sex:

female

Details on test animals and environmental conditions:

Preliminary study : 10 females
Experimental group: 20 females
Control group : 10 females

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

water

Challenge

Route:

epicutaneous, occlusive

Vehicle:

water

Details on study design:

On day 1 an area of the dorsal skin from the scapular region (approximately 4 x 6 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 mllsite) were made at the border of a 2 x 4 cm area in the clipped region as follows:

A) The test substance diluted to 0.1 % (wlw) with physiological saline,
B) Freunds' Complete Adjuvant (FCA, Difco, Detroit, U.S.A.), 50:50 with distilled water for injection (pyrogen free).
C) The test substance, at twice the concentration used in (A), emulsified in a 50:50 mixture of Freunds' Complete Adjuvant.

Positive control substance(s):

yes

Remarks:

Formaldehyde (sensitivity check)

Results and discussion

Positive control results:

Clear positive results after challenge with 0.25% formaldehyde in distilled water.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

2%

No. with + reactions:

5

Total no. in group:

20

Clinical observations:

No symptoms of systemic toxicity were observed in the animals during the study.

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. .

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

2%

No. with + reactions:

5

Total no. in group:

20

Clinical observations:

No symptoms of systemic toxicity were observed in the animals during the study.

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. .

Results 3

Reading:

other: Controls

Group:

negative control

No. with + reactions:

1

Total no. in group:

10

Clinical observations:

No symptoms of systemic toxicity were observed in the animals during the study.

Remarks on result:

other: Reading: other: Controls. Group: negative control. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. .

Any other information on results incl. tables

CONTROL GROUP:

Eight, one and one animal showed a skin reaction in response to the 2%, 1% and 0.5% test substance concentration, respectively. These skin reactions were characterised by red spots, scaliness.

EXPERIMENTAL GROUP:

Sixteen, one and two animals showed a skin reaction in response to the 2%, 1% and 0.5% test substance concentrations, respectively. These reactions were characterised by redness, crust, swelling and scaliness. Taking into account the intensity of the responses and comparing these with the reactions seen in the control animals, five animals showed a positive skin reaction in response to the 2% concentration.

No symptoms of systemic toxicity were observed in the animals during the study.

No mortality occurred during the study.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions used in this study, treatment with the substance resulted in a sensitisation rate of 25 per cent.

Applying the rating of allergenicity described by Kligman A.M. (1966) on the results obtained in this test, the substance is considered to have mild sensitising properties. However, it does not meet the criteria for classification (≥ 30 % responding at > 1 % intradermal induction dose ). See ECHA Guidance on the Application of the CLP Criteria